The following data is part of a premarket notification filed by Harvest Technologies, Corp. with the FDA for Smartjet Grafting Liquid Applicator, Models Sk/s & Lk/2.
| Device ID | K020252 |
| 510k Number | K020252 |
| Device Name: | SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 |
| Classification | Syringe, Piston |
| Applicant | HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Contact | John D Bonasera |
| Correspondent | John D Bonasera HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD, SUITE 100 Plymouth, MA 02360 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-24 |
| Decision Date | 2002-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35020583514547 | K020252 | 000 |
| 35020583514530 | K020252 | 000 |
| 35020583514523 | K020252 | 000 |
| 35020583514516 | K020252 | 000 |
| 05020583514539 | K020252 | 000 |
| 05020583514522 | K020252 | 000 |
| 05020583514546 | K020252 | 000 |
| 05020583514515 | K020252 | 000 |